Transcutaneous Limb Recovery Post-Stroke (TRICEPS)
Research type
Research Study
Full title
An efficacy and mechanism evaluation of transcutaneous vagal nerve stimulation for upper limb recovery post-stroke – a randomised, controlled, multi-arm, multi-stage, adaptive design trial
IRAS ID
308254
Contact name
Arshad Majid
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN20221867
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
TRICEPS aims to determine whether Transcutaneous Vagus Nerve Stimulation (TVNS) paired with rehabilitation therapy of the affected arm post stroke improves motor function in participants with arm weakness following a stroke.
Over 15 million people suffer a stroke worldwide annually. One third are left with arm weakness causing difficulties with daily activities. Whilst rehabilitation therapy does help post stroke, the benefits are modest. In a recent trial, stimulating the Vagus nerve (VN) while the participant moved their weak arm resulted in better arm recovery compared with therapy alone. However, the stimulator was surgically implanted, and the VNS was triggered by a therapist in hospital.
In this trial, we will stimulate the VN in a non-invasive way at home. The VN will be stimulated through the skin via an earpiece using a TVNS device.
We will aim to recruit 243 participants who have arm weakness following a stroke between 6 months to 10 years ago and are no longer undergoing active rehabilitation therapy. The trial will be conducted across approximately 15 stroke centres across the UK. Eligible participants will be consented, and baseline measures will be taken.
Participants will be randomised to one of three groups:
-Group A: Self-delivered therapy (1hr/week, 5x a week) with sham TVNS (negligible stimulation), like a placebo
-Group B: Self-delivered therapy (1hr/week, 5x a week) with TVNS
-Group C: Self-delivered therapy (1hr/week, 5x a week) with TVNS plus additional TVNS (1 to 8 hours) while performing activities of daily living.The treatment period is 12 weeks and will take place at the participant's home. The main outcome, improvement in arm function, will be assessed once the treatment has finished and again 6 months after the start of treatment.
Via a sub-study, we will also assess if TVNS produces changes in the brain via fMRI and, in some cases, PET scans.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0209
Date of REC Opinion
13 Oct 2022
REC opinion
Further Information Favourable Opinion